HydroPICC Dual Lumen 80002004Recalls & reported problems

Access Vascular, Inc. · HydroPICC Dual Lumen – Maximal Barrier Kit · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850030354068), received between May 24, 2024 and May 24, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K213550); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Aug 31, 2023Class IIOpen, Classified
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Z-0115-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Device problems

Break1

Patient problems

Inflammation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 24, 2024Break; Break
REPORT OF A LEAK/BREAK IN A DUAL LUMEN CATHETER.
Patient problems: Inflammation
MAUDE report 19392189 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213550. One submission often covers many models, so check the product and lot details in each record.

Z-0114-2024 · Aug 31, 2023 · Open, Classified
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002

Device details

UDI-DI	`00850030354068`
Brand	HydroPICC Dual Lumen
Model	80002004
Company	Access Vascular, Inc.
Product code	LJS · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Class	Class 2
FDA submission	K213550
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Feb 8, 2024

Device type (GMDN): Peripherally-inserted central venous catheter

A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

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All Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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